Apparatus and method for fat and cellulite reduction using rf energy in combination with magnetic muscle thermostimulation (ems)

ABSTRACT

A system for cosmetically treating a patient&#39;s skin or body with one or more EMS coils and/or RF electrodes mounted on a planar holder; a hydrogel containing gel pad, the gel pad being positionable between the holder and the skin tissue; wherein the gel pad being of a material that is biocompatible and conducts RF and/or EMS energy when EMS energy is applied from the one or more EMS coils; a programmable controller to activate the one or more EMS coils; the programmable controller, after the planar holder is applied to the skin tissue, being configured to activate one or more of the plurality of EMS coils to provide treatment in the form of stimulation to the skin tissue.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 17/670,872, filed Feb. 14, 2022, which is a continuation applicationof U.S. application Ser. No. 17/315,297, filed May 8, 2021, which is acontinuation application of PCT/IB2020/051700, filed Feb. 27, 2020,which is related to U.S. Provisional Application No. 62/812,123, filedFeb. 28, 2019, U.S. Provisional Application No. 62/884,099, filed Aug.7, 2019, and U.S. Provisional Application No. 62/908,741, filed Oct. 1,2019, the entire contents of each of which are herein incorporated byreference, and to which priority is claimed as to each.

FIELD OF THE INVENTION

The present invention relates to apparatus and methods for the treatmentand reduction of adipose tissue, cellulite and tissue irregularities(such as wrinkles) in a human body using radiofrequency energy (RF)and/or electromagnetic muscle stimulation (EMS).

BACKGROUND OF THE PRESENT INVENTION

Devices and methods are known in the industry which are designed totreat (read reduce) adipose tissue in humans. Some of these employ laserenergy to essentially melt away the fat cells, other devices utilizecold temperatures around 0 to 5 degrees C. to cause the freezing anddestruction of fat cells, and still other devices use RF energy which istargeted to the layer of the fat cells to heat the cells and cause themto melt and then be drained away by the body's internal systems.

It is to the very latter of these technologies that the presentinvention is directed, in which RF energy is employed to provide moreeffective treatment over larger areas of the body to reduce treatmentduration. By treating larger areas of the body during a singleprocedure, overheating of the epidermis is avoided and the totaltreatment time is reduced.

In addition, one of the issues that an operator may encounter is anecessity of holding the handpiece that provides the treatment energy tothe patient's skin tissue during the treatment, thus requiring theoperator (unnecessarily) to be occupied holding the device during thetreatment.

Also, a known problem with energy generating devices, such asradiofrequency (RF) generating devices is that, when applied to skintissue, the RF energy may produce hotspots so that one portion of theskin tissue is treated differently than other portions of the skintissue.

While various radiofrequency electrodes are known and used, one problemencountered in using radiofrequency devices in the skin treatment isthat the shape and size of the electrode or electrodes may well affectthe amount of energy that is imparted to the skin tissue. Obviously, itis desirable that the energy provided to the skin tissue be uniformacross the entire area affected by the radiofrequency electrode orelectrodes.

In known devices employing radiofrequency technology, it is typical tomanually set a selected frequency at which the radiofrequency energy isimparted. This may have certain disadvantages in providing a thoroughtreatment of the skin tissue through different depths of the skin tissueanatomy.

While it may be known to provide a matrix of radiofrequency electrodesin a single unit or housing, it is important that the individualelectrodes in the matrix be controlled in a manner to provide the mostefficacious treatment to the skin tissue, and, obviously, if the matrixof RF electrodes could be controlled automatically the results would beless operator time spent on a particular treatment as well as a moreeffective treatment of skin tissue treatment conditions.

One consequence of applying radiofrequency or any other kind of energyto the skin tissue is that of generating heat and thus causing skintissue heating. In particular, excessive heating of the epidermis is oneaim to be avoided so that there is not discomfort or pain on the part ofthe patient. Some systems avoid or at least attempt to avoid pain byproviding the radiofrequency treatment only sporadically or at giventimes for given periods, as in a pulsed manner. With the desire that thetreatment, be given on more or less continuous basis so that thoroughtreatment may be had as well as shortening the total amount oftreatment, it may be useful to provide cooling of the epidermis.

Other known devices use systems to cool the skin that is under the RFelectrodes, such as the provision of passages of a coolant in theelectrode, or electronic devices (such as fans or even Peltier cells).However, this solution does not allow the temperature sensor placedbetween the electrode and the skin to correctly measure the skintemperature. Not knowing the temperature of the skin issue, the operatormay be unable to know what is be the temperature inside the tissues indepth, for example in the fat, and thus this in turn impairs the overallefficacy of the treatment.

If the aim of the radiofrequency treatment is to reduce adipose tissue(fat) content deep in the skin tissue, the regimen of applyingradiofrequency energy may well be different from the regimen of applyingradiofrequency energy if the desire is to eliminate or reduce wrinklesin parts of the skin tissue that are located above the level of adiposetissue. Thus, if a device or technique can be developed to identifywhere, for example, the selected tissue lies within the skin tissue,then treatment can be adjusted automatically so that the desired levelof radiofrequency treatment may be initiated.

In those instances of treatment in which the treatment device may bemoved over the body portions of the skin tissue, it is obviouslydesirable that each portion of the skin tissue desired to be treated isactually treated, but also it may be important that portions of the skintissue not be overtreated by the device being repeatedly placed over thesame area tissue that had previously been treated.

In other radiofrequency devices, it is common that the radiofrequency beprovided as one or more radiofrequency energy pulses. While this may bedone in order to control the heating of the underlying skin tissue,discontinuities between pulses may not make the treatment regime asefficient as it could be. It may be that a regime in which theradiofrequency energy is provided on a more or less continuous basis andperhaps even over different frequencies may have the result of morethorough treatment.

It is to overcome one or more the disadvantages of present systemsidentified above that the present invention is addressed and describedin the following detailed description of the present invention.

SUMMARY OF THE PRESENT INVENTION

In an aspect, a method for cosmetically treating a patient's skin tissueincludes: providing a plurality of RF electrodes mounted on a cooledsilicone planar holder; providing a programmable controller to activateone or more of the plurality of electrodes; the method includes thesteps of: a. applying the planar holder to the skin tissue; b. securingthe planar holder to the patient; c. activating one or more of theplurality of RF electrodes one of individually, sequentially, orsimultaneously in a continuous manner to provide treatment; d. selectingone or more frequencies in a scan mode for application by the one ormore of the plurality of RF electrodes; thereby the skin tissueunderlying the one or more RF electrodes is selectively treated byactivation or one or more of the plurality of RF electrodes at one ormore selected frequencies in a continuous manner.

In another aspect, the planar holder further comprises a cooling devicefor maintaining a constant skin tissue temperature when the one or moreof the plurality of RF electrodes is activated using sensors thatmeasure the skin tissue temperature in areas surrounding the pluralityof RF electrodes. The cooling device may include one or more of: one ormore Peltier elements, one or more fan devices that implement aircooling, or circulating cooling fluids. Further, the one or moreelectrodes may comprise a plurality of electrodes arranged in a matrix.The cooling device may be mounted centrally within the matrix of RFelectrodes.

In an aspect, a console includes a programmable controller and a userinterface, the console being operable to control the activation of theone or more plurality of RF electrodes mounted on the planar holder. Theholder further may include one or more skin temperature sensors, andwherein the one or more temperature sensors transmit skin temperaturemeasurements to the programmable controller. The holder may furthercomprise one or more impedance measurement circuits, and wherein the oneor more impedance circuits transmit skin impedance measurements to theprogrammable controller. The programmable controller may activate theone or more of the plurality of RF electrodes in response to the sensedtransmitted impedance measurements, and the controller may vary the RFelectrode frequency selected in response to the sensed transmittedimpedance measurements. The frequencies selected may be one or more of:0.475 MHz, 1.0 MHz, 2.0 MHz, 4.0 MHz and 6.0 MHz (+/−20%) and may beselected one of: individually or in a scan mode. The planar holder mayfurther comprise a securing belt to secure the planar holder to thepatient's skin tissue, as well as the planar holder may have two sides,one side being a thermally conducting silicone rubber material tocontact the skin tissue and the second side being of a non-thermallyconducting material. The plurality of electrodes may be removablymounted on the planar holder. The electrodes may be mounted in theplanar holder such that on the side of the holder that contacts the skintissue, the plurality of RF electrodes is spaced from and are not incontact with the skin tissue. The method may include the step ofapplying a solid gel plate between the electrodes and the skin, andwherein the solid gel plate is preferably of an adhesive material thatis biocompatible and conducts RF energy.

In an aspect, a system for cosmetically treating a patient's skin tissueincludes: a plurality of RF electrodes mounted on a cooled siliconeplanar holder; a programmable controller to activate one or more of theplurality of electrodes; the programmable controller, after the planarholder is applied to and secured to the skin tissue, being configured toactivate one or more of the plurality of RF electrodes in a continuousmanner to provide treatment in a scan mode at one or more frequenciesfor application by the one or more of the plurality of RF electrodes;thereby, the skin tissue underlying the one or more RF electrodes isselectively treated by activation or one or more of the plurality of RFelectrodes at one or more selected frequencies in a continuous manner.

In a further aspect, a system for cosmetically treating a patient's skintissue and transdermally delivering substances into the skin tissue,includes a plurality of RF electrodes mounted on a silicone planarholder; a hydrogel containing gel pad positionable between the holderand the skin tissue; the gel pad including materials for transdermaldelivery into the skin tissue; the gel pad being of a material that isbiocompatible and conducts RF energy; a programmable controller toactivate one or more of the plurality of electrodes. The programmablecontroller, after the planar holder is applied to and secured to theskin tissue, being configured to activate one or more of the pluralityof RF electrodes in a continuous manner to provide treatment in a scanmode at one or more frequencies for application by the one or more ofthe plurality of RF electrodes. Thereby, the skin tissue underlying theone or more RF electrodes is selectively treated by activation or one ormore of the plurality of RF electrodes at one or more selectedfrequencies in a continuous manner; and, whereby the one or more RFelectrodes when activated generate heat in the skin tissue, the heatgenerated causing the materials within the gel pad to be transdermallydelivered into the skin tissue at a predetermined temperature. Thematerials for transdermal delivery are selected from: pharmaceuticalmaterials, cosmetic materials, and time release materials. Further, theplanar holder further comprises a cooling device for maintaining aconstant skin tissue temperature when the one or more of the pluralityof RF electrodes is activated using sensors that measure the skin tissuetemperature in areas surrounding the plurality of RF electrodes. Thesystem may further comprise a console, the console including theprogrammable controller and a user interface, the console being operableto control the activation of the one or more plurality of RF electrodesmounted on the planar holder. The planar holder may have two sides, oneside being a thermally conducting silicone rubber material to contactthe skin tissue and the second side being of a non-thermally conductingmaterial. The plurality of electrodes may be removably mounted on theplanar holder. The electrodes may be mounted in the planar holder suchthat on the side of the holder that contacts the skin tissue, theplurality of RF electrodes is spaced from and are not in contact withthe skin tissue.

In a further aspect, one or more EMS coils may be mounted on the planarholder, the one or more EMS coils being mounted in the vicinity of thecenter position on the planar holder. The programmable controller may beconfigured to activate the plurality of RF electrodes and the one ormore EMS coils one or more of: simultaneously or sequentially.

In yet another aspect, a system for cosmetically treating a patient'sskin tissue includes a plurality of RF electrodes mounted on a siliconeplanar holder; one or more EMS coils mounted on the silicon planarholder; a programmable controller to activate one or more of theplurality of electrodes and the one or more EMS coils; the programmablecontroller, after the planar holder is applied to and secured to theskin tissue, being configured to activate one or more of the pluralityof RF electrodes in a continuous manner to provide treatment in a scanmode at one or more frequencies for application by the one or more ofthe plurality of RF electrodes; the programmable controller furtherbeing configured to activate the one or more EMS coils; whereby the skintissue underlying the one or more RF electrodes is selectively treatedby activation or one or more of the plurality of RF electrodes at one ormore selected frequencies in a continuous manner and by the one or moreEMS coils; and, whereby the one or more RF electrodes when activatedgenerate heat in the skin tissue and the one or more EMS coils providestimulation to the skin tissue. The one or more EMS coils may be mountedin the vicinity of the center position on the planar holder. Theplurality of RF electrodes number one of: 1 or 4. The programmablecontroller is configured to activate the plurality of RF electrodes andthe one or more EMS coils one or more of: simultaneously orsequentially.

In yet a further aspect, a method for cosmetically treating a patient'sskin tissue and transdermally delivering substances into the skin tissueincludes: providing a plurality of RF electrodes mounted on a siliconeplanar holder; providing a hydrogel containing gel pad positionablebetween the holder and the skin tissue; wherein the gel pad includingmaterials for transdermal delivery into the skin tissue; the gel padbeing of a material that is biocompatible and conducts RF energy;providing a programmable controller to activate one or more of theplurality of electrodes; applying and securing the planar holder to theskin tissue surface; the programmable controller, after the planarholder is applied to and secured to the skin tissue surface, activatingone or more of the plurality of RF electrodes in a continuous manner toprovide treatment in a scan mode at one or more frequencies forapplication by the one or more of the plurality of RF electrodes;whereby the skin tissue underlying the one or more RF electrodes isselectively treated by activation or one or more of the plurality of RFelectrodes at one or more selected frequencies in a continuous manner;and, whereby the one or more RF electrodes when activated generate heatin the skin tissue, the heat generated causing the materials within thegel pad to be transdermally delivered into the skin tissue at apredetermined temperature.

In an aspect, a method for cosmetically treating a patient's skin tissuecomprises: providing a plurality of RF electrodes mounted on a siliconeplanar holder; providing one or more EMS coils mounted on the siliconplanar holder; providing a programmable controller to activate one ormore of the plurality of electrodes and the one or more EMS coils;applying and optionally securing the planar holder to the skin tissue;the programmable controller, after the planar holder is applied to andsecured to the skin tissue, activating one or more of the plurality ofRF electrodes in a continuous manner to provide treatment in a scan modeat one or more frequencies for application by the one or more of theplurality of RF electrodes; the programmable controller further beingconfigured to activate the one or more EMS coils; whereby the skintissue underlying the one or more RF electrodes is selectively treatedby activation of one or more of the plurality of RF electrodes at one ormore selected frequencies in a continuous manner and by the one or moreEMS coils; and, whereby the one or more RF electrodes when activatedgenerate heat in the skin tissue and the one or more EMS coils providestimulation to the skin tissue. The stimulation type from EMS coils isin the form of muscle contractions due to the sudden and intensevariations in the magnetic field induced onto the muscles.

In a further aspect, a system for cosmetically treating a patient's skintissue, comprises:

one or more EMS coils mounted on a planar holder; a hydrogel containinggel pad, the gel pad being positionable between the holder and the skintissue; wherein the gel pad being of a material that is biocompatibleand conducts EMS energy when EMS energy is applied from the one or moreEMS coils; a programmable controller to activate the one or more EMScoils; the programmable controller, after the planar holder is appliedto the skin tissue, being configured to activate one or more of theplurality of EMS coils to provide treatment in the form of stimulationto the skin tissue.

In yet another aspect, a method of cosmetically treating a patient'sskin tissue, comprises: providing one or more EMS coils mounted on aplanar holder; providing a hydrogel containing gel pad, the gel padbeing positionable between the holder and the skin tissue; positioningthe gel pad between the holder and the skin tissue; wherein the gel padbeing of a material that is biocompatible and conducts EMS energy whenEMS energy is applied from the one or more EMS coils; providing aprogrammable controller to activate the one or more EMS coils; theprogrammable controller, after the planar holder is applied to the skintissue, activating one or more of the plurality of EMS coils to providetreatment in the form of stimulation to the skin tissue which may be, asmentioned, in the form of muscle contractions due to the sudden andintense variations of the magnetic field induced on the muscles. The gelpad may underlie both the RF electrodes and the EMS coils or mayunderlie just the RF electrodes or just the EMS coil(s).

In an aspect, the method further comprises the step of securing theplanar holder to the skin tissue. The step of securing the planar holderto the skin tissue may be through one of a belt or an adhesive. Themethod may include an accelerometer, and further comprising the steps ofsetting the most suitable parameters to obtain the best performingmuscle contractions. Further, the method may include the step ofpositioning the gel pad under the RF electrodes, or under the EMS coil,or under both.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A through 1C illustrate one embodiment of a RF energy applicatorof the present invention.

FIG. 2 illustrates one embodiment of the structure of RF electrodes inconnection with the embodiment of FIGS. 1A though 1C.

FIG. 3 illustrates a solid gel plate which may be interposed between theskin tissue and the RF electrode(s) side closest to the skin tissue.

FIG. 4 illustrates experimental results achieved with the device andtreatment parameters available in the present invention.

FIGS. 5A-5C illustrate a RF electrode filled with a thermal gel-typematerial.

FIGS. 6A-6H illustrate a modification of the embodiments of FIGS. 1A-1Cto include a source of electromagnetic energy.

FIGS. 7A and 7B illustrate monopolar and bipolar applicators.

FIGS. 8A through 8H illustrate the structure and design of an energyapplicator.

FIGS. 9A through 9H illustrate the structure and design of anotherenergy device.

FIG. 10 illustrates a combination applicator having one or more gel padspositioned to interface with the skin tissue of the patient.

DETAILED DESCRIPTION OF THE PRESENT INVENTION A First Embodiment:Structure of an RF Energy Device

Turning now to FIGS. 1A through 1C, these figures show a firstembodiment of the present invention. The device, numbered as 100, may bereferred to as herein a radiofrequency belt. The belt 100 includes aplanar holder body 102 which may be made from thermally conductivesilicone rubber, plastic or any other known non-electro-conductivematerial.

Mounted on the holder body 102 are a number of radiofrequencyelectrodes. While in FIG. 1A there is shown six such radiofrequencyelectrodes, 104 a-104 f, it is to be understood that a number less ormore may be implemented in mounted on the holder body 102. In order tomaintain the holder device 102 stationary and mounted on a patient'sbody, a belt 106 attached to the body 102 may be implemented. The belt106 may wrap around a body portion such as torso or the leg or the armsor the chin or the cheeks, and may include a conventional latchingmechanism such as a Velcro. An adhesive material may also be utilized.The holder body 102 also may include a Peltier-type solid state cooler108 shown mounted centrally to the array of electrodes 104 a to 104 f,but may be placed in other positions on body 102. In addition, multiplePeltier coolers may be implemented and mounted on the body 102. Asuitable cable 110 is shown connected to the body 102 and may be used toconnect with a suitable known console which would supply electricalpower for the Peltier cooler 108 and provide power to the electrodes 104a through 104 f. One purpose of the Peltier cell, applied to the belt,is to cool the skin under the electrodes, but, through the planar holderthermally conductive silicone rubber, to in addition maintain a constanttemperature (28° C. for example) across the entire skin area that isaround the electrodes.

FIG. 1C illustrates the holder 102 but without the RF electrodes mountedwithin it, to be described below in connection with FIG. 2 . FIG. 1Billustrates the holder 102 from the bottom side, that is, the side whichplaces the electrodes in the vicinity of the skin tissue.

The holder 102 as mentioned may preferably be made of silicon rubber orsome other material which has a high thermal conductivity on the side itwill be in contact with the skin while being thermally insulated on theother side. It is known that silicone is biocompatible and is easilysterilize or disinfected, but several other high thermal conductivitymaterials also could be used.

In addition, the holder 102 may include one or more temperature sensorsto monitor temperature and transmit those temperatures to a programmablecontroller mounted in the console to provide the relative averagetemperature of the areas of the of skin tissue in and around theradiofrequency electrodes. The sensors, which may be positioned atselected and multiple points on the silicone rubber holder 102, maydetect the skin temperature under the electrodes but preferably onlythat of the skin around the electrodes.

Other temperature sensors may be mounted on the inside of theradiofrequency electrodes themselves in order to be able to detecttemperature of the electrodes and to send that information as necessaryor desired to the console.

The controller is able in this way to detect the temperature differencebetween the one detected under the skin and the average temperaturedetected on the skin around the area treated by the electrodes. Byhaving this information, the controller can be programmed to increase ordecrease the temperature of the skin around the electrodes, reducing thepain or discomfort of the patient.

It also may be desirable that the radiofrequency electrodes be easilyremoved from the holder 102 in the event that it becomes necessary toclean the electrodes or one or more of the electrodes becomes defectiveor to simply allow an operator to change the number of electrodesdesired to provide a particular type of treatment.

Peltier coolers, if employed, will, of course, generate heat on the sideof the cell not in contact with the skin tissue and it may be necessaryto actively cool and withdraw that heat away from the cell. This may bedone by air circulation means or may be accomplished by liquid coolingin which the device of FIG. 1A may be modified to include water linesthat provide cooling water or other fluid to or to the vicinity ofPeltier coolers to withdraw heat and dispose of the heat generated.

Turning now to FIG. 2 , this figure illustrates in a side view detailsof the electrode structure and the electrode mounting on the holder 102.Holder 200 includes a ledge 204 which surrounds the electrode 202 andholds it in place. As mentioned above, due to the construction of theholder 200, the electrodes may be removed and/or replaced. The ledge 204prevents the electrode from falling through the holder 200, but as wellprovides a standoff from the skin tissue 208 so that the electrode doesnot come into contact directly with the skin tissue 208. A uniformconductive RF hydrogel plate 206 may be inserted or otherwise positionedwithin the holder 200. With this arrangement, the edge of the electrodedoes not come into contact with the skin. It is known in the relevantart that RF energy emitted by electrodes thickens on the edges, both ifthe electrodes are circular in shape, but especially if they arerectangular. The concentration of energy on the edges can create burnsto the skin, and to avoid this, the operator is forced to shorten theduration of the treatment or to not exceed temperature levels higherthan 42-44 degrees C.

The electrode 202 may be constructed in a manner to include an outerhousing that contains the active device which produces theradiofrequency energy. The active device may not occupy the entireinterior of the electrode 202, and the remainder of the interior of theelectrode housing 202 may be filled with a suitable grease, oil orthermal gel which has the function of homogenizing the heating of theelectrode 202 so that across electrode 202 uniform heating and energy isimparted to the skin tissue. This arrangement may also reduce “hotspots” and heating differential across the extent of the electrode. FIG.5 illustrates an enlarged view of a RF electrode, in this case acircular electrode, containing a thermal gel or grease.

As shown in FIG. 5A, a circular electrode assembly 500 includes a volume502 for containing thermal grease or gel, a temperature sensor 504, allassembled within the housing 500. FIG. 5B shows an exploded view of theRF circular electrode assembly 500 with an electrically insulating cover506 and FIG. 5C a perspective view of the same assembly. It is to beunderstood that the electrode assembly 500 may, for example, be mountedas in the electrode 202 shown in FIG. 2 .

Turning now to FIG. 4 , this figure shows a RF electrode assembly likethat shown as 500 in FIG. 5 mounted on a gel pad assembly like the gelpad assembly 300 from FIG. 3 . The patient's skin tissue to be treatedby the present invention is located on the non-visible side of the gelpad 300. It is to be understood that the shape of the gel pad, the shapeof the RF electrode assembly and number of pads and electrodes may bedetermined by the number of openings in a holder assembly like theholder assembly 102 of FIG. 1 .

As can be seen in reference to FIG. 1A, it appears that the shape of theelectrodes is generally rectangular. However, this is not the onlyconfiguration which is workable and desirable. For example, circularelectrodes provide a uniform dispersion of radiofrequency energy fromthe electrode due to their shape. Rectangular and other polygonal shapedelectrodes have the disadvantage that at the hard corners, there can bediscontinuities in the generation of radiofrequency energy resulting indifferent heating patterns generated when applied to the skin tissue.

In the electrodes 104 shown in FIG. 1A, while shown as being rectangularin shape by way of example, it is noted that the edges all corners ofthe rectangular shaped electrodes are rounded so that the differentialin radiofrequency energy generation and heating are minimized whilestill providing electrodes that are large enough to be able to treatlarge areas of the skin tissue. Other shapes, such as squares orcircular, may also be implemented.

While Peltier cooling has been discussed previously, it may be desirableto ensure that the cooling that takes place should be limited to areasaround the electrodes, in the vicinity of, but not under, the one ormore electrodes for a number of reasons. As shown in FIG. 1A, forexample, the central positioning of the Peltier cooler 108 will causethe holder 102 to emanate cooling of the areas of the holder 102surrounding the RF electrodes 104 a-f, such that the skin temperatureunder the holder 102 is more or less around the normal body constanttemperature of 28 degrees C., for example.

Thus, with the arrangement of cooling Peltier cells in the presentinvention, the exact temperature of the skin under the RF electrodes isknown, and, as such, the system parameters can be manipulated to deliverthe desired amount of heat into the depth skin tissue, during the entiretreatment.

Many known RF systems cool the electrode(s) themselves, for example withthe circulation of coolant, and the electrode(s) in turn cool down theskin. This is done to avoid pain or discomfort to the patient whenreaching temperatures above 42° C.

By maintaining the temperature of a large area of the skin around theelectrodes at constant and physiological values (e.g. T=28° c.), throughthe planar holder 102 of the present invention, even if hightemperatures (45° c.) are reached under the electrodes, the patient doesnot experience an unbearable discomfort or pain, because themicrocirculation of the blood drains a portion of excess heat in thearea below the electrode. But below the epidermis and at the fat level,the temperature increases steadily until adipose (fat) cells isdestroyed.

In addition, the surface of the electrode side which are nearest to theskin tissue may be coated with a thin layer of biocompatible classicmaterial such as PTSD or Rilsan© (medical grade), or be coated with aceramic material, which is electrically insulated to preventnon-insulated metal electrode causing electrostatic charges of plasmadischarges, which in turn may provide discomfort or pain in the form ofburns to the patient. Another way to overcome this problem to preventanywhere occurring on the electrode is to make the electrode of anAluminum alloy (such as alloy EN AW 6082), with surface treatment with ahard oxide, impregnated with PTFE (medical grade). This may provide longterm, extensive use of the electrode without the risk of thinning of theinsulation layer away while still guaranteeing biocompatibility.

If the surface or face of the holder 102, shown in FIG. 1B, is placed onthe skin tissue, there still may not be perfect contact between holder,its radiofrequency electrodes, and the skin tissue. This may be due to,for example, the stiffness of the material of which the holders made or,more likely, irregularities in the skin tissue surface, such as curvedsurfaces, indentations and wrinkles in the skin tissue. Should this bethe case, the delivery of RF energy may well be nonuniform and mayresult in uneven heating of the skin tissue. Thus, the holder 102 ofelectrodes are not pressed down hard by the operator during mounting orany movement of the holder as this can create micro discharges or unevendelivery of energy across the skin tissue surface. This may occur evenwhen a belt is used to secure the holder 102 to the patient's skintissue.

To reduce this problem, manufacturers presently may employ a water-basedgel of the type used in ultrasound treatments which is spread on theskin areas in which the electrodes will be placed. This solution,however, has limits, because with the movement of the electrode on thesurface, the gel spreads and partly may be absorbed in the skin, againcreating the energy discontinuity problems discussed above.

To remedy this problem, a preferred solution is the use of a solidconductive RF energy gel plate which is placed on the skin tissue and isdesigned to even out any discontinuities.

Such gel plates are known in the art but, as understood, have not beenused in connection with devices like the present invention. The gelplate may be made in three layers: a layer of adhesive gel that contactsthe skin, an intermediate layer consisting of a superconductingintermediate grade carbon film (in the form of a thin film or retinalayer), and an outer layer of conductive gel adhesive that may beapplied to the surface of the electrode or electrodes facing the skintissue. FIG. 3 shows such an energy gel plate, showing the layers ofadhesive conductive gel 302 and 304 and the layer of superconductingintermediate grade carbon film 306.

The energy gel plate described above provides certain advantages. Thanksto the middle layer having intermediate carbon grade, the radiofrequencyenergy will be distributed to the skin surface homogeneously, so thateven heating of the skin tissue occurs. The gel plate also transmits theRF energy very well to the skin to even deep tissues, reducing the skinimpedance and therefore lowering surface heating, thus preventing the RFenergy from heating the skin more on the epidermis level.

While the carbon film has been described above, it may be advantageousto instead (or even in addition) utilize one or more layers of graphene.Graphene is a known material but is believed not heretofore been used incombination with the other layers of the hydrogel gel pad componentsdisclosed above, nor in the combination RF and EMS device disclosed inU.S. Provisional Application No. 62/884,099, filed Aug. 7, 2019,incorporated herein by reference. Graphene is a material which is anexceptional thermal and electrical conductor, is flexible as well asbiocompatible.

As a result, it will be possible to have a temperature at the epidermislevel somewhere in the vicinity of 43 to 45 degrees C. without thepatient suffering discomforting burns or pain, as localized heating iseliminated or very much reduced, aided by the cooled planar holder thatdrains excess heat.

The use of a gel plate also allows warming of the tissue to take placefaster and produces even higher value temperature of up to 47/48° C.without harming the skin tissue due to the uniform distribution ofenergy. Thus, placing of the energy gel plate between the skin tissueand the radiofrequency energy generating device avoids discontinuitiesin skin tissue causing discontinuities in heating of the skin tissue.

Operation and Control of the RF Energy Device

While heretofore the description has been made generally related to thestructure of the device or appliance which is applied to the skintissue, the present section of this application is directed to thecontrol application criteria pertinent to the treatment regime appliedto various patients.

In prior art devices, the predominant method of providing RF treatmentshas been through a pulsed regime, that is, the RF energy is applied in adiscontinuous, pulsed manner. In the present invention however, the RFenergy may be applied in a continuous manner.

A programmable controller, which is part of the device or a console ofthe invention herein that provides the RF energy also has thecapability, in a generally autonomous fashion, to choose a single ormultiple range of frequencies of RF energy to be applied to the skintissue. The programmable controller may be in communication with adevice to measure impedance of the skin tissue. Impedance thus may bemeasured, then forwarded to the program controller, which will in turnmay adjust the frequency applied to the skin tissue.

Preferably, more than one frequency range of RF energy may be employedwith the present invention. Preferably these frequencies may be: 0.475Mhz, 1.0 Mhz, 2 Mhz, 4 Mhz and 6 Mhz, but these may be varied as suitsthe particular application of RF energy, the treatment applied, and thecondition of the skin tissue. Generally, the program controller willchange modify the frequency applied based on the temperature to whichthe skin tissue is raised, impedance measurements, and type oftreatment.

Thus, the above-mentioned console may include not only controls forsetting the RF energy, but may also include a computer memory whichstores, among other things, settings of frequency ranges and timesduring which such frequencies are applied, in connection with thespecific treatment to be applied. Thus, the console may include a userinterface through which an operator can not only custom-design treatmentregimes, but also may include preprogrammed treatment regimens that maybe selected and then applied to the patient's skin tissue.

As an example, the RF treatment device of the present invention may beplaced on a patient's skin. As a first step, the treatment device willmeasure the impedance of the skin tissue and forward that reading to theoperator and to the console's user interface. If desired and if theimpedance measurement fits within one or more of the preprogrammedtreatment regimes, the operator may then push a button or lever to starttreatment. The console will then direct the controller apply RF energyto the skin tissue in a sequence of frequencies within the parameters ofthe preprogrammed treatment regime. Once commenced, sensors connectedwith the RF treatment device may measure temperature of the skin tissueand impedance levels while the treatment is being provided. The lengthof the treatment and the frequency of the RF energy applied may beadjusted according to the measurements above. The program controller mayinclude a feedback mechanism that adjusts the timing of the treatmentand the particular frequency of RF energy applied in response tomeasurements of such parameters as skin temperature and skin tissueimpedance.

Further, as described above, the treatment device may include multipleRF electrodes that may be activated or deactivated, individually,sequentially, or even simultaneously, in accordance with the particulartreatment regime to be applied. Thus, for example, a first RF electrodeor electrodes which is/are positioned over a particular portion of thepatient's anatomy and skin tissue may be activated while otherelectrodes contained in the RF electrode matrix may be deactivated orthese RF electrodes may be activated to operate at a frequency orfrequencies different from that of the first particular RF electrode(s).This arrangement provides maximum flexibility and control and may becontrolled autonomously in response to either or both of the setting ofa preprogrammed treatment regime or as a result of feedback from eitherone or both of the temperature sensor or sensors or impedancemeasurements of the skin tissue.

Having the ability to generate different frequencies of RF treatmentfrom different RF electrodes provide the advantage of achievingdifferent physiological effects in a single treatment. For example, byselecting particular RF frequencies and particular RF electrodes, thepatient may be treated in a way that adipose tissue may be reduced whileat the same time wrinkles that may already be present, or which mayarise from the shrinkage of adipose tissue may also be treated. Forexample, if the operator intends to perform a skin rejuvenationtreatment, the controller, based on the input from the operator on theuser interface and based on the impedance level detected, chooses andimplements the most suitable frequency according to the treatmentdesired, which could be a frequency of, for example, 6 MHz, while anadjacent electrode is activated to carryout skin tightening treatment,in which case a controller may choose, for example, a frequency of 4MHz.

A further advantage of providing different frequencies of treatment isthat by doing so and by varying such frequencies, the ability of thehuman body to react to the heat caused by the RF energy throughsweating, pain and or discomfort may be reduced. In changing thefrequency of treatment and applying such a continuous manner, heat,which is induced by the RF treatment, spreads progressively and evenlyat a similar speed through the various layers of skin tissue so there isonly a gradual increase in temperature over the entire thickness of theskin tissue treated, which is not occur when devices operated at asingle frequency.

As a consequence, the mechanisms of defense to deal with induced heatwithin the human body are slower to react, thus allowing a gradualincrease in a temperature and even reaching temperature levels importantfor effective treatment in a way that there is no pain or discomfort dueto high localized excess heating. Thus, by operating changingfrequencies, the heat generated by the action of the RF treatmentspreads more evenly and at a faster pace, while the temperature of theskin tissue rises gradually through the treatment area at differentdepths of treatment into the skin tissue.

Further, the change in frequency of the treatment regimen of RFapplication changes the depth into the skin tissue of areas oftreatment. Thus, different depths in the skin tissue can be treated bymanipulating the frequencies applied. In addition, with the matrix of RFelectrodes as seen in FIGS. 1A through 1C, it can be seen that, forexample, electrodes 104 e and 104 d are closer in distance apart than,for example, electrodes 104 a and 104 d. Thus, activating such pairs ofelectrodes, in combination with varying the frequencies of applicationof the RF energy allows the operator to select different depths oftreatment into the skin tissue.

As another example, if an operator wants to act both on cellulite and toreduce adipose tissue in a single treatment, a preprogrammed treatmentregime may choose a frequency of 1 MHz to treat cellulite while anotherfrequency that best reduces the number of fat cells may be 0.475 Mhz,either by different selected RF electrodes or the same electrodes withdifferent applied frequency changes. It is important, since thephysiology of the skin tissue differs somewhat from patient to patient,to know where the desired level skin tissue is located so as to providethe most efficacious treatment regime. This information may be providedthrough impedance measurements both before treatment begins and duringtreatment, and such measurements are then fed to the controller in theconsole which then, in turn, adjusts the particular frequency to beapplied and the time during which the frequency is applied to the skintissue.

Thus, the present invention provides the following advantages overpreviously known devices and treatment regimes. First, the presentinvention enables the operator to carry out treatments in a more or lessautonomous manner, directed to a particular type of treatment applied toa particular portion of the human skin tissue, based both on impedancemeasurements as well as skin tissue measurements. Second, the presentinvention provides the ability to treat multiple areas with a pluralityof electrodes, again without operator intervention since it is thecontroller that measures impedance and skin temperature and adjusts andselects a specific electrode or specific electrodes at selectedfrequencies. Third, the present invention facilitates the ability toprovide treatment at different depths of the skin tissue so thatdifferent physiological issues may be treated during the same treatmenttime that the patient is subjected to at the operator's facility.Fourth, the present invention permits the power applied to the RFelectrodes to be controlled automatically by the controller on the basisof the impedance measured, a set target temperature and the particulartreatment regime selected. Fifth, by continuously reading impedance andtemperature levels, in the event that the temperature level in the skintissue rises above safe levels, such information may be transmitted tothe controller which then either adjusts the treatment regime to safelevels or aborts the treatment altogether.

While the above discussion has been concentrated on a matrix of RFelectrodes formed in a more or less planar structure, it is envisionedthat the present invention also may apply to different shaped RFelectrode holders, including even a small diameter, oval orcircular-shaped device which may be employed within a vaginal handpiece.In this embodiment, the use of different RF electrodes to providedifferent frequencies allows the operator to provide multiple treatmenteffects during the same treatment, such as, reducing skin laxity as wellas activation of the microcirculation of pelvic muscle tissues and evenincluding reducing urinary incontinence.

A Second Embodiment: Transdermal Delivery Methods

Transdermal delivery is a technique that allows active substances to beconveyed into the tissues, in a completely painless and non-invasivemanner. The molecules to be conveyed into the tissue, generallymicroparticles or nanoparticles, can be phytocomplexes, cosmetics andpharmacology according to the therapeutic need.

The basic idea in transdermal delivery is to penetrate the skin barrierso as to be able to transport active ingredients and substances directlyinto the necessary areas, below the epidermal layer. Use of thistechnique obviates the need to use needles or syringes for theadministration of the substances, nor does it involve the use of acids.

Transdermal delivery makes it possible to convey a greater quantity ofcosmetic or medicinal molecules in a completely painless andnon-invasive way, which accumulate and spread little by little overtime, guaranteeing a prolonged action over time and above all providegreater therapeutic efficacy.

The use of topical medical or cosmetic substances, associated withtransdermal delivery, makes possible a very low interaction with theblood circulation, reducing any gastrointestinal toxicity of themolecules conveyed.

This method is effective, has a very high tolerability index and is easyto use for the operator.

With transdermal delivery, the following can be effectively treated:cutaneous hypotonia; wrinkles; water retention and cellulite; stretchmarks; localized fat deposits; skin spots; acne scars; toning (not onlyfor the neckline or the arms, but also the buttocks and breast);alopecia; attenuation of neuralgic or muscular pains or realpathologies, conveying in this case ad hoc pharmacological preparations.The most common of these, for example, are: cervical-back pain, tendoncalcifications; acute inflammation; muscle contractures; and cicatricialfibrosis.

On a technical level, transdermal treatment has numerous advantages: itis defined as selective, as it is effective locally on the treated areasand does not affect healthy areas; lower quantities of substances can beused thanks to the high percentage of product conveyance; it does nottend to overload the skin and body metabolism; the molecules duringvehiculation remain intact and are therefore more effective than thoseused with invasive methods; and, the results have a natural effect andin most cases are visible from the first treatment sessions.

To carry out transdermal delivery there are various devices such asiontophoresis, devices that emit microcurrents, and recently also byusing radiofrequency (RF).

Their use, with a different mechanism depending on the technology, isaimed at overcoming the epidermal barrier by “opening” the“intercellular gates”, and thus penetrating in depth with the substanceschosen and applied by the doctor or other operator.

Thanks to the high percentage of product conveyance through transdermaldelivery, it does not tend to overload the skin and body metabolism. Themolecules during vehiculation remain intact and are therefore proven tobe more effective than those used with invasive methods. The resultshave a natural effect and in most cases are visible from as early as thefirst treatment sessions.

Further, lower quantities of the treatment substances can be used thanksto the high percentage of product conveyance. The skin and bodymetabolism do not tend to become overloaded. The molecules duringvehicular remain intact and therefore more effective than those usedwith more invasive methods.

Radiofrequency (RF) energy may provide a modern transdermal deliverymethod and system, but previous RF implementations and technologies havea number of different limitations. First, they are dependent on theparticipation and activity of the operator, i.e. the operator mustcontinuously move a handpiece with the electrode applied, capacitive orresistive, regardless of the area to be treated. The speed of movementand the pressure is subjective; therefore, the distribution of theactive principles cannot necessarily be uniform throughout the area. Inaddition, a conductive RF cream, often lacking in active ingredientsuseful both in the aesthetic and therapeutic fields, must necessarily beused. With the massaging movement by the handpiece operator with theelectrode and with the increase in heat, the cream may be quicklyabsorbed and therefore the operator must take several breaks tosupplement supplying the cream to the skin surface. Further, typicallyafter the treatment it is necessary to clean the treatment area from thenon-absorbed cream to prevent the patient from staining the patient'sclothing. Also, only one frequency is typically employed and thereforethis results in limited treatment action, since the level of depth ofaction depends above all on the frequency of the electrode employed.

RF technology often does not control temperature and impedance. The useof conductive substances varies skin impedance depending on the amountpresent which in some areas will be absorbed while in others not. Thisvariety of impedance in the area to be treated affects the temperaturelevel and the effectiveness of the treatment.

Thus, one purpose of the present apparatus and method is to modify thefirst-described device and to enable it able to carry out transdermaldelivery in an effective way. It is to this subject matter that thepresent embodiment is directed.

As previously described above, a gel pad is shown in FIGS. 3 and 4 withreference numeral 300 and described further therein.

The present invention includes and adds to the device shown in FIGS.1A-1C, as well as FIG. 2 and FIGS. 5A-5C, a particular pad which iscomprised of an adhesive hydrogel that is biocompatible and conductiveto RF energy.

The hydrogel pad may be applied to the area to be treated and theapplicator that supplies the RF energy (such as that shown in FIGS. 1Ato 1C) A number of differently sized and shaped applicators can be madeand then applied so as to cover large or odd-shaped areas on the skinsurface, and then activated without the operator having to be engagedduring treatment.

As a matter of background, a hydrogel is a colloid formed by polymericchains of molecules dispersed in water, whose content of the aqueousmedium can exceed 99%. From a strictly technical point of view, ahydrogel can be defined as “a three-dimensional, hydrophilic polymernetwork capable of absorbing large quantities of water or biologicalfluids”.

Different natural compounds can form hydrogels, such as in the case ofagar and various polysaccharide molecules, but also artificial compoundssuch as silicones and polyacrylamide. The presence of numeroushydrophilic groups within the dispersed molecule is fundamental. Giventhe nature and composition of the hydrogels, these are commonly referredto as hydrocolloids.

Among the different possibilities, hydrogels, thanks to theirbiocompatibility, are reported, for example, for use as a support forthe growth of cells in tissue engineering, in breast implants and inpharmaceutical preparations for the treatment of burns and wounds,thanks to its ability to gradually release the active ingredients it maycontain.

Hydrogel therefore represents an excellent support for being associatedwith both cosmetic and pharmacological or phytocomplex activeingredients.

The gel pad described above and shown in FIGS. 3 and 4 may be made withhydrogels and constructed in a suitable way to deliver RF energy in auniform way. For some time, it has been possible to realize them withthe insertion of these active principles, normally in a nano moleculeformat, but also with classic dimensions.

The specific hydrogel of the present invention may have an acid-basecharacteristic, which allows the controlled release of a drug orcosmetic active ingredient. There are natural hydrogels such as the Agaror artificial ones such as pNIPAAM (poly-N-isopropylacrylamide), PVA(polyvinyl alcohol) or PVP (polyvinylpyrrolidone).

To carry out its therapeutic effect desired, an active ingredient mustbe available in a certain dose for a given time in a specific place.Therefore, controlled release systems capable of satisfying theserequirements must be appropriately designed so that the active principlecan be released with the desired kinetics, in response to some externalstimuli (sensitive systems), and/or in certain environments (systems fortargeted administration).

Hydrogel-based release systems are excellent candidates when there is aneed for controlled release, as is currently widely used in variousfields (pharmaceutical, agri-food, etc.).

The hydrogel used in the gel pads has been suitably modified in thechemical structure to make it “stimuli-responsive”, that is, to make itsproperties change in response to external stimuli, such as temperaturevariation, for example.

Following an increase in temperature and upon reaching the desiredtemperature, the controlled and slow release of the active material willbe introduced into the hydrogel lattice.

Therefore, types of hydrogels will vary depending on the activeingredient inserted and the aesthetic or therapeutic purpose.

By way of non-limiting example, if it is desired to treat periocularwrinkles, hyaluronic acid can be used in the hydrogel lattice so that itcan be released at 39° C. following the supply of energy by RF.

When it is desired to introduce the active ingredients to a skin tissuedepth to help the destruction of fat by the heat brought to 45° C. by RFenergy, typical active ingredients useful for this purpose may beselected from caffeine, and phosphatidylcholine, etc. which will bereleased starting from 40° C. rather than 42° C., depending on the typeof body fat, if abdominal rather than present in other parts of thebody.

A Third Embodiment: RF Combined with an EMS/Magnetic Source

Another aspect of the present invention is a modification of the deviceshown in FIGS. 1A-1C through 5C and described above. The modificationsare shown in the embodiments of FIGS. 6A through 6H as well as FIGS. 7Aand 7B.

The above description of RF energy application discloses the heating ofsubcutaneous fat to a temperature of 45° C. and its maintenance for afew minutes; this causes the induced destruction of fat cells, in anon-invasive way. At those temperature conditions, the fat cellsdegenerate and are phagocytosed by apoptosis from healthy cells.

The liquefied fat that escapes from the fat cells partly crystallizesand partly fills the intracellular spaces, from which it is removed moreor less slowly from the venous lymphatic system in the days followingthe treatment.

But, if the patient's venous lymphatic system is not enough efficient,the liquefied fat still present in the intracellular spaces is slowlyreabsorbed with the development of new adipose cells, making treatmentefficient in only a limited way, according to the physiologicalconditions of the patient at the time of treatment.

To overcome this limit in the amount of fat and cellulite that can beeffectively reduced, at the same time as the action of the RF isdelivered by the device, through applicators which are positioned on thespecific area of the skin tissue, High Intensity Magnetic Energyimpulses may be able to provoke powerful muscle contractions.

High-Intensity Magnetic impulses can create induced currents which,associated with RF-induced heating, can generate powerful musclecontractions known as muscular thermostimulation.

Typically, electro-stimulation is used for muscle contraction.Electrical stimulation is usually obtained by applying a current to thesurface of the body, using electrodes in contact with the skin. Thiscurrent generates an electric field in the underlying tissue, causingthe stimulation of nerves and/or muscles when the electric field innerve/muscle cells is above a certain threshold.

The stimulation generates muscle contractions that increase blood flowin the muscle and consequently increase muscle strength.

The electric field induces muscle contractions in two different ways.

The first method is the stimulation of motor neurons (nerve cells) whichthen excites the muscle fibers by chemical transmission. A single motorneuron innervates many muscle fibers. One motor neuron and the musclefibers that the neuron innervates are called “motor unit”. All themuscle fibers in a motor unit contract together and develop strengthwhen they are stimulated by the motor neuron. This type of musclestimulation is “passive” and is generated by electrostimulation.

The second method is direct stimulation of muscle fibers (muscle cells).Muscle fibers are cylindrical cells of 50-100 um in diameter. Sometimesthey extend for the entire length of a muscle. Muscle fibers are groupedinto bundles surrounded by connective tissue. The contraction occurs dueto changes in the current/electric field applied to individual musclefibers by the electrodes. This active stimulation happens due to thecurrents induced by the high-intensity pulsed magnetic field.

Therefore, the electric field and the electrical current induceddirectly into the muscle is an important factor for the purpose ofmuscle contraction, rather than the current applied to the skin.Besides, an electric current applied directly to the skin may cause harmand cause burns if it is too intense.

Contractions of the muscle bands induced by impulsive currents generatedby high-intensity pulsed magnetic fields, unlike the muscle contractionsresulting from classic electro-stimulation on the skin, are powerful andwide, and create a “pump effect” on the venous and lymphatic circulationsystem effectively removing the liquefied fat still present in theintra-cellular spaces, avoiding fat re-absorption.

In addition, fat heating induced by RF indirectly involves the musclebands, and this improves the overall capability of the muscles.

It is a known art in physiotherapy that the high intensity magneticfield impulses emitted by the applicators cause currents induced in thecovering tissues causing the contraction of the muscles also placed indepth.

The level of muscle contraction and the depth of action of magneticmuscle stimulation depends on the level of intensity, which is normallybetween 1 T and 2 T.

But if the muscle is not “ready” to contract the effects of the magneticpulse on the muscle is reduced.

Athletes who perform competitive sports activities, before starting suchactivities, perform physical exercises with the aim of “pre-heating” themuscles.

By pre-heating the muscles and keeping them at a constant temperaturethroughout the treatment by supplying RF, muscle contraction reaches itsmaximum level.

It has been verified that the ideal temperature at which musclesoptimize their viscoelastic characteristics is about 39°/40° Celsius. Atthis temperature, the speed of muscle contraction increases by 20%,because blood flow increases, activation of sensory receptors improves,tissues viscosity decreases, elasticity of tendons improves nervousconduction speed increases, and enzyme activity changes positively.

In conclusion, the synergy of RF-induced heating and muscle contractionsas a result of intense magnetic field-induced electrical currents,produces the following effects:

-   -   Radio frequency-induced heat forces the lipid panel to expel        intra-cellular fluid in order to compensate for the thermal        action. The liquid leaked from fat cells as a result of the        induced heat is then removed quickly from the affected area        thanks to the active contraction of the muscles, stimulated by        the vibrating platform. Therefore, there is an immediate,        verifiable and effective venous-lymphatic drainage, as well as        the re-activation of microcirculation that completes the        elimination of intracellular fluids in the following days;    -   More powerful and intense muscle contraction, resulting in        increased muscle toning, firming, and strengthening;    -   Production of testosterone due to muscle contractions.        Testosterone is the inhibitor of the formation of fat tissue;    -   Muscle thermostimulation, produced by the association of muscle        contraction with RF-induced heating, creates an intense        peripheral vasodilation action which tones the skin and prepares        it to absorb the active ingredients contained in cosmetic        products.

The devices shown in FIGS. 6A-6H differ from those of FIGS. 1A to 1C inthat an EMS (Electro Magnetic Stimulation) coil is included in thepad-like structure/applicator/pad.

Turning first to FIG. 6A, that figure shows a pad 600 that is shownincluding a positive RF electrode 602 and a negative RF electrode 604,thus forming a bipolar RF circuit. Further, an EMS coil 606 ispositioned centrally on the pad 600.

FIG. 6B is similar to FIG. 6A, except with the addition of a furtherpair of electrodes 608 and 610.

FIGS. 7A and 7B illustrate implementation of the combined RF/EMS in amonopolar setup and bipolar setup, respectively.

FIGS. 8A through 8H illustrate the design of an applicator that may beRF only or RF combined with EMS, or even EMS only. For example, in FIGS.7A and 7B, the RF electrodes may be eliminated so that the device is EMSonly. Further, a suitable console device may contain separate EMS and RFhandpieces so that RF and EMS may be applied to the patient eithersimultaneously or sequentially in any desired order: RF then EMS, EMSthen RF, RF and EMS together. In addition, a source of skin cooling maybe applied to the patient's skin tissue, this giving three modalities:RF, EMS and cooling. All or only some of these may be applied and theymay be applied in any desired sequence or order suing all or only someof RF, EMS and cooling. For example, RF may be applied then cooling, orEMS then cooling.

Also, the gel pad 300 of FIGS. 3 and 4 , which was described inconnection with the RF pad and being places between the patient's skinand the RF device may also be effectively used in connection with eithera combined RF and EMS device or an EMS-only device, such as that shownin FIGS. 8 , again being placed between the patient's skin and the EMShandpiece. In fact, in the embodiments shown in FIGS. 8 and 9 , the gelpad(s) may be situated under the RF portions or under the EMS portion ofthe applicator or both. In addition, in the case of the positioning of agel pad under one of the RF or EMS portions, but not the other portion,the plate or other surface which may contact the skin may be extended toencompass the gel pad portion such that the portion not having the gelpad comes into contact with the skin of the patient. By way of example,FIG. 10 , derived from FIG. 9H, shows a side end view of a combined RFand EMS applicator 2100 having three pads 2102, 2104 and 2106. The pads2102 and 2014 are positioned under the RF portions of the applicator andpad 2106 under the EMS coil(s) portion of the applicator 2100.

Obviously, the number of RF electrodes and even the number of EMS coilsmay be increased as desired depending on the desired treatment. In thecase of multiple RF electrode pairs and EMS coils, they may be wired soas to be selectively activated by a suitable programmable controller.

FIGS. 6C through 6H illustrate various possible modifications of thestructure/applicator/pads of FIGS. 6A and 6B.

Further, the sequences of activations may be variably controlled, suchas simultaneous or sequential activation of the RF electrodes and theEMS coil(s); they may be operated at a single frequency ormulti-frequencies, as described in the above-mentioned patentapplication.

In addition, again as described above, an adhesive pad between the pad600 and the skin tissue may be inserted or not inserted, and the belt106 of FIG. 1A may be provided (or not) to secure the pad 600 to thepatient's body.

The device of the present invention operates at frequencies ranging from300 Khz to 4 MHz and thus at much lower frequencies than in the priorart; thus it acts on deep tissues, and is absorbed for the most part bythe fat, reaching preferably the temperature of 45° C., with itsmaintenance and control by the system, but could also heat up to 50° C.,with the added benefit of not causing burns on the skin.

Moreover, the device of the present invention simultaneously emits toemission of RF energy, through a particular applicator or handpiecesupported and fixed on the area to be treated. Also, the high intensitypulsed magnetic energy (EMS) is able to generate muscular contractionsof considerable intensity. The emission of RF and EMS energy can alsotake place simultaneously, separately or sequentially with presetperiods of action and pauses for the activation of each such energysource.

The high intensity pulsed magnetic (EMS) energy is inputted in thecentral area, but it is possible to invert the RF energy in the centerand on the sides the emitting coils producing an intense variable fieldof the applicator, and with a magnetic field intensity that can reach 3T. The applicator may have different dimensions to adapt it to the areasto be treated, but preferably square, rectangular or round, example ofwhich are illustrated in FIGS. 6A-6H.

The applicator, one or more applicators per device, but preferably two,may be equipped with an accelerometer capable of detecting the level ofoscillation following the setting of the parameters that allow themuscles to contract and release.

For example, the operator may position the applicator on anon-stimulated muscle band and indicate to a suitable controller on amachine that this is the starting zero position. From this point, anoperator can then set the usual parameters such as frequency andintensity to check by the accelerometer how much the muscle lifts.

If the operator does not evaluate it satisfactorily, move the applicatorand/or modify the parameters to get a better answer.

The applicator has a shape that allows it to house the electrodes fromwhich the RF will be emitted.

The electrode numbers may be more than one and placed all around thevicinity of the area from which the High Intensity Magnetic (EMS) Energyis emitted.

RF emission, therefore, may be capacitive if the electrode surface iselectrically isolated, or resistive, if the surface is electricallyconductive. Depending on the disposition of the electrodes, the emissioncan be bipolar or monopolar (with return plate). The electrodes may becircular, or rectangular, oval, etc.

The applicator with RF electrodes will be placed on the area to betreated even without any conductive medium, and adhered to the patient'sbody with elastic bands or belts or straps, etc.

However, in order to reduce the skin impedance for a better penetrationof the RF, between the supporting surface on the skin of the applicatorand the skin itself, it may be useful to insert a conductive medium,such as, in a non-limiting example, a RF conductive gel, or gel cream.

Preferably, it may be useful to apply on the surface of the applicatorthat comes into contact with the skin, a particular double-sided gel paddisclosed in the main portion of this application, of such size to coverthe entire surface of the applicator. A pad with hydrogel reducesimpedance and spreads the RF energy emitted by the electrodes, thusavoiding the formation of hot spots and therefore excessive heating ofthe skin.

Excessive heating of the skin, it is to be remembered, is one of thelimits that prevents other RF systems on the market from bringing thetemperature of the fat to 45° C. and maintenance at that temperature.

The pad with hydrogel may be designed to be enriched also with activeingredients, pharmaceutical or cosmetic, slowly release, temperaturecontrolled by the controller, as described in the present application.That is, the active ingredients could be encapsulated, and their releasewould take place only when a specific temperature level is reached forthe purpose of the treatment.

FIGS. 8A through 8H illustrate the design of an applicator that may beRF only or RF combined with EMS, or even EMS only.

FIGS. 9A through 9H illustrate the design of an applicator that is acombination of RF and EMS.

1. A system for cosmetically treating a patient's skin tissue,comprising: a pad comprising on a first side an adhesive andbiocompatible layer configured to be placed on the patient's skintissue; at least one radio frequency (RF) electrode mounted on a secondside of the pad and configured and operable to apply RF energy to theskin tissue beneath the pad to thereby heat one or more layers of theskin tissue; at least one muscle stimulating element mounted on thesecond side of the pad and configured and operable to generate a signalthat stimulates one or more muscles in vicinity of the skin tissuebeneath the pad thereby causing contraction and relaxation of the one ormore muscles; and a programmable controller configured and operable toactivate the at least one RF electrode and the at least one musclestimulating element at one or more frequencies; thereby applying one ormore preprogrammed treatment regimes to the skin tissue, the treatmentregimes comprising skin rejuvenation, skin tightening and fat reduction.2. The system according to claim 1, wherein said pad is made from athermally conductive silicone rubber.
 3. The system according to claim1, wherein said pad comprises an intermediate layer between said firstand second sides, the intermediate layer comprising a flexible graphene.4. The system according to claim 1, wherein said pad comprises anintermediate layer between said first and second sides, the intermediatelayer comprising a thin carbon film.
 5. The system according to claim 1,wherein said adhesive and biocompatible layer comprises hydrogel thatreduces skin impedance and spreads the RF energy thereby avoiding theformation of hot spots and excessive heating of the skin.
 6. The systemaccording to claim 1, wherein said adhesive and biocompatible layercomprises materials for transdermal delivery into the skin tissue underthe heat generated by the RF electrodes.
 7. The system according toclaim 1, wherein said at least one muscle stimulating element isconfigured to generate an electrical signal that stimulates a motorneuron that innervates the one or more muscles which then excites musclefibers of the one or more muscles and cause the contraction andrelaxation of the one or more muscles.
 8. The system according to claim1, wherein said said at least one muscle stimulating element isconfigured to generate a high-intensity pulsed magnetic field signalthat directly stimulates the muscle fibers of the one or more musclesand cause the contraction and relaxation of the one or more muscles. 9.The system according to claim 1, comprising an accelerometer mounted onthe second side of the pad and configured and operable to detect thelevel of muscle contraction and relaxation; thereby enabling a user ofthe system to adjust activation parameters of the muscle stimulatingelement to achieve the desired level of the muscle contraction andrelaxation.
 10. The system according to claim 1, comprising a coolingdevice mounted on the pad and being configured for maintaining aconstant skin tissue temperature when the skin tissue is heated by theactivation of the RF electrodes.
 11. The system according to claim 1,comprising one or more skin temperature sensors mounted on the pad andoperable to measure and transmit skin temperature measurements to theprogrammable controller, thereby enabling adjusting parameters of thetreatment regime.
 12. The system according to claim 1, comprising one ormore impedance measurement circuits mounted on the pad and operable tomeasure and transmit skin impedance measurements to the programmablecontroller, thereby enabling adjusting parameters of the treatmentregime.